On June 15, 2022 Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC), developer of treatments for rare and orphan indications, including Parkinson Disease and various cancers, reported that the Company presentation at BIO International Convention is now available at View Source (Press release, Oncotelic, JUN 15, 2022, View Source [SID1234616007]).

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The JVCo IPO- is on track for 2023 with anticipated minimum valuation of 200M / Range 1-5B
OT-101 is being combined with most known immunotherapies including MPM/Keytruda/ Merck, NSCLC/Tecentriq/Genentech, and others are in various stages of initiation
OT-10 treatment of high- risk COVID patients reduced mortality from 100% to 50%, p=0.003.

On June 15, 2022 Jazz Pharmaceuticals (NASDAQ: JAZZ) and Redx (AIM: REDX) reported the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for JZP815, a pan-RAF inhibitor for the treatment of solid tumors and hematologic malignancies that contain mutations in the MAPK pathway, enabling Jazz to proceed with initiating a clinical trial for JZP815 (Press release, Redx Pharma, JUN 15, 2022, View Source [SID1234616005]). As a result, a milestone payment of USD $5 million from Jazz payable to Redx has been triggered.

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The milestone payment was triggered under the Agreement in which Jazz acquired Redx’s pan-RAF inhibitor programme, announced on 10 July 2019. Redx carried out development activities up to the completion of IND-enabling studies. Today’s milestone is on top of USD $6.5 million already received under the collaboration and Redx remains entitled to development, regulatory and commercial milestone payments as well as incremental tiered royalties in mid-single digit percentages, based on any future net sales.

Preclinical data from this pan-RAF programme was recently presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) conference in March. JZP815 is a precision pan-RAF inhibitor with a differentiated mechanism of action, and Jazz expects to assess its utility in treating several types of difficult-to-treat solid tumours where there remains significant unmet patient needs. Jazz expects to advance JZP815 into a Phase 1 clinical programme and, when initiated, JZP815 will be the fifth compound discovered by Redx to enter the clinic.

Lisa Anson, Chief Executive Officer of Redx, commented: "I am delighted that the IND application for the pan-RAF inhibitor, JZP815, has been accepted. When Jazz commence the clinical programme this will become the fifth drug candidate discovered by Redx to enter the clinic, further validating our world-class research and development capabilities. We value the strong relationship we have built with Jazz Pharmaceuticals and look forward to continuing our work together."

Rob Iannone, M.D., M.S.C.E., Executive Vice President, Global Head of Research and Development of Jazz Pharmaceuticals, commented: "We’re excited to advance JZP815, a precision pan-RAF inhibitor with a differentiated mechanism of action, into a clinical trial programme. JZP815 may represent a significant advancement in the pan-RAF inhibitor class by not inducing paradoxical pathway activation that can stimulate the growth of certain cancers. The JZP815 programme exemplifies our continued progress in expanding our early-stage oncology pipeline, and in developing therapies with the potential to address unmet patient need. Redx has an exceptional team of research and development scientists and together we have formed an outstanding collaboration, leveraging the strengths of both companies."

Jazz and Redx also have a separate collaboration agreement to discover and develop drug candidates in the RAS-RAF-MAP kinase (MAPK) pathway, where Redx is again responsible for research and preclinical development activities up to IND application to the FDA.

About Pan-RAF inhibitors
Mutations leading to uncontrolled signalling in the RAS-RAF-MAPK pathway are seen in around one third of all cancers. The Company’s pan-RAF inhibitor programme aims to overcome resistance mechanisms associated with clinically approved B-RAF selective drugs.

The RAF kinases A-RAF, B-RAF and C-RAF are an integral part of the RAS-RAF-MAPK pathway, with B-RAF mutations commonly seen in the clinic. Although most B-RAFV600E/K mutant skin cancers are initially sensitive to approved B-RAF selective drugs, treatment resistance often develops leading to disease progression. Moreover, B-RAFV600E mutant colorectal cancers are surprisingly insensitive to these B-RAF selective drugs as single agents due to the compensatory functions of other RAF family members. Importantly, B-RAF selective therapies fail to show clinical benefit against the more prevalent RAS-mutated tumours.

About JZP815
JZP815 is an investigational, pre-clinical stage pan-RAF kinase inhibitor that was discovered and developed using state-of-the-art screening methodologies and medicinal chemistry. JZP815 targets specific components of the mitogen-activated protein kinase (MAPK) pathway that, when activated by oncogenic mutations, can be a frequent driver of human cancer. JZP815 potently inhibits both monomer- and dimer-driven RAF signaling (e.g., RAS-induced), prevents paradoxical pathway activation induced by BRAF selective inhibition, and is active against class 1, class 2, and class 3 BRAF mutants, as well as BRAF fusions and CRAF mutants. JZP815 is not currently approved for use anywhere in the world. JZP815 is part of Jazz’s growing early-stage R&D pipeline focused on solid tumours and targeted therapy.

On June 15, 2022 Pierian, a global leader in advanced clinical genomics technology and services, reported with Syapse, a leading real-world evidence company, a new joint collaboration that will benefit patients of the AdventHealth Cancer Institute in Central Florida (Press release, PierianDx, JUN 15, 2022, View Source [SID1234616004]). The collaboration combines Pierian’s leading-edge clinical genomics workflow, and precision medicine services with Syapse’s real-world evidence solutions designed to improve outcomes for patients with cancer.

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The partnership will enable AdventHealth clinicians to offer more comprehensive diagnostics for oncology patients in Central Florida allowing for more personalized treatment options due to improved capabilities to identify known and emerging biomarkers critical for cancer treatment and progression. It will also enable more efficient identification of clinical trials and treatment options for patients based on their molecular testing results and similar patients in the Syapse Learning Health Network (LHN). Pierian and Syapse will collaborate on optimizing AdventHealth’s internal genomic testing capabilities for all patients who may benefit to improve the actionable insights gathered from test orders and genomic results allowing a deeper understanding of the relationship between these insights and real patient outcomes.

Pierian partners with clinicians and medical facilities worldwide to establish high-quality clinical genomics programs and a global sharing network. With advanced interpretation technology connected to the most comprehensive knowledge base, Pierian’s unique, adaptive learning algorithms make intelligent associations between comprehensive datasets and individual patient results. Post analysis and interpretation, clinical reports are easy to generate which empowers providers with genomic insights to fulfill the promise of precision care.

"At Pierian, we are laser-focused on driving clinical adoption of next-generation sequencing worldwide," said Lindsay Mateo, CBO of Pierian. "Our collaboration with AdventHealth and Syapse allows patients in Central Florida to benefit from local, comprehensive genomic testing supported by Pierian. The clinical picture for each patient is strengthened when all patient datasets are combined and leveraged through the Syapse LHN."

Syapse’s oncology platform enables precision medicine across large health systems, placing the power of real-world evidence in the hands of oncologists, allowing them to consider how specific treatments have worked for patients around the country, and to make more informed decisions about the treatment journey of their own patients.

"Increasingly, cancer care is tailored not just to the primary cancer type, but to the uniqueness of each person – a result of the transformative insights in genetics and genomics," said Thomas Brown, MD, MBA, chief medical officer of Syapse. "But making the most of these insights means having enough data to achieve the precision patients expect, that’s why bringing in real-world data that goes beyond a single health care delivery site is so vitally important."

Together, this collaboration brings together the complementary strengths of three leaders in precision oncology, genetic testing, and real-world evidence creating new opportunities for better insights and outcomes for cancer patients.

On June 15, 2022 Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, reported that the Company has acquired a minority stake in Israel-based Squalus Medical, the inventor and developer of the StingRay Laser System (the "StingRay System"), a novel laser-based thermal ablation technology designed for treatment of previously inoperable cases of epilepsy and for improvement of outcomes and enablement of new treatment options for oncology procedures, including those treating brain, prostate, liver, breast and lung cancers (Press release, Innovation Pharmaceuticals, JUN 15, 2022, View Source [SID1234616001]).

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The StingRay System combines new fiber optic technology with an advanced laser console and computerized intelligent control that allows an excellent match between the structure of tumors and epileptic focal points and the energy delivery, while protecting vital functional areas against thermal damage. The console integrates advanced imaging modalities, and guides the physician, making sure the treatment is adjusted to the specific patient needs with real time energy control.

The StingRay System is supported by Squalus’ proprietary technologies that deliver remarkable properties for controlling laser energy. These include:

· DiLITT — Directional Laser Interstitial Thermal Therapy. DiLITT provides the ability to treat distorted or irregular shapes through accurate control of the angular energy distribution.

· ExLITT — Extended LITT. ExLITT offers the ability to easily treat large volumes through radial control of the energy.

· APM — Advanced Planning Module. These are the software tools that control the laser and do the matching between the lesion shape and energy using smart AI based algorithms.

"What Squalus is doing is truly revolutionary with the potential to help millions of patients around the world that are precluded from procedures to provide them relief from epilepsy and cancer because of the origin of their disease," commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. "M&A activity in recent years has demonstrated a robust market for new, safe, and effective laser-based technologies and we believe that the Squalus technology has the potential to attract the attention of leaders in the medical space. Squalus will pursue the FDA 510(k) pathway for marketing clearance in the U.S. and the corresponding process for a CE Mark in Europe. This was an ideal investment for us to build value and diversify our portfolio. We consider the market to be substantial and the timeline shorter than pharmaceuticals. We intend to remain active in analyzing other potential value-add opportunities that can strengthen our company."

"We are thrilled with the investment from Innovation Pharmaceuticals as we are at a major inflection point with completing development of the StingRay system and beginning the process towards commercialization," said Gil Shapira, co-founder of Squalus Medical. "The medical community is facing significant challenges with treatment of resistant epilepsy and various cancers, creating an immediate need for an advanced and highly controlled energy tool like the StingRay system to improve patient outcomes and enable new treatment modalities in key verticals. Our goal is to provide this solution in the coming years via the U.S. Food and Drug Administration 510(k) pathway and the European Union’s CE Mark, processes I am very familiar with."

Epilepsy is the most prevalent serious neurologic condition in the world, affecting about 70 million people. Unfortunately, 30%-40% of those patients are afflicted with drug resistant epilepsy, meaning they receive no relief from medication.1

Squalus Medical was founded by Moshe Eshkol and Gil Shapira both highly experienced specialists in surgical lasers and medical devices. Squalus and the development of the StingRay system are also supported by a grant from the BIRD Foundation (View Source), a bi-national organization supporting Israel-US collaboration. Gil Shapira brings 26+ years of engineering and product development and management experience, with over 17 years in the surgical laser industry. Gil owns and manages neoLaser, a company he founded in 2012, and led to revenue growth and profitability, with a 43% CAGR on its way to more than 1200 global installations and performing 50,000+ surgeries annually in over 30 countries. Previously, Gil led product development and marketing at OmniGuide, a successful high-growth laser-based medical device spin-off out of the Massachusetts Institute of Technology (MIT).

1 The epidemiology of drug‐resistant epilepsy: A systematic review and meta‐analysis, Kalilani et al., Epilepsia 2018;59:2179–2193

On June 15, 2022 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported the appointment of Faye Feller, M.D., to Executive Vice President and Chief Medical Officer, effective July 9, 2022 (Press release, Geron, JUN 15, 2022, View Source [SID1234616000]). Dr. Feller will succeed Dr. Aleksandra Rizo, Geronʻs current Chief Medical Officer, who will transition to a consultant role to the Company, as Senior Medical and Regulatory Advisor. Outside of Geron, Dr. Rizo has accepted a leadership position with a privately held discovery and preclinical-stage platform biotechnology company.

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Dr. Feller has been instrumental in the design, execution and management of the imetelstat development program for the past seven years, starting when she served as a medical leader in Janssen’s hematology program. She has continued her work on imetelstat since 2019, as Geronʻs Vice President of Clinical Development reporting to Dr. Rizo.

"Faye has been a cornerstone in the history of imetelstat’s clinical development. Since coming to Geron, she has played a strategic role in designing and driving execution of our Phase 3 clinical trials. In addition, she serves as the primary medical point of contact between Geron and our clinical investigators, leads the preparation of data for assessment by the data monitoring committees, and is preparing for the top-line readout of our IMerge Phase 3 trial in lower risk myelodysplastic syndromes, which is expected in early January 2023," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "With her background as clinical lead for multiple clinical trials while at Janssen, and as an attending hematologist at Memorial Sloan Kettering Cancer Center, Faye is highly qualified to assume her new role as our Chief Medical Officer."

When Dr. Feller becomes Chief Medical Officer, Dr. Rizo will transition to the consultant role, where she will continue to be involved in key imetelstat development and regulatory activities. These include assessment of data for top-line results from the ongoing IMerge Phase 3 trial in lower risk myelodysplastic syndromes (MDS) and, assuming supportive top-line results, through the planned FDA New Drug Application submission and acceptance process for imetelstat in lower risk MDS.

"Aleksandra has made tremendous contributions to the development of imetelstat," Dr. Scarlett continued. "Her leadership in building and mentoring a deep and experienced development organization is evident with the internal promotion of Faye as Chief Medical Officer. We appreciate the continuity in involvement Aleksandra will provide as Faye assumes her new responsibilities."

"It has been a privilege to work with Chip and the Geron team to advance this innovative first-in-class telomerase inhibitor, imetelstat, into the late stages of clinical development. I remain confident in the potential of imetelstat to be a transformative treatment for patients with hematologic malignancies, and as such, I am fully committed to continuing to contribute to the imetelstat journey through the potential New Drug Application submission and acceptance process. In particular, I am eager to see the Phase 3 top-line results from the lower risk MDS trial expected in early January 2023," Dr. Rizo said. "I am also completely confident that imetelstat will be in excellent hands with Faye and the rest our team at Geron, many of whom I have worked with side-by-side on imetelstat over the past seven years, and for whom I have the greatest respect."

Prior to joining Geron, Dr. Feller was Senior Director at Janssen Research and Development, LLC (Janssen) and both a Compound Lead and Study Responsible Physician for multiple clinical trials of early and late-stage development assets at Janssen, including the IMbark Phase 2 clinical trial of imetelstat. Prior to Janssen, Dr. Feller was an attending physician in the leukemia department of Memorial Sloan Kettering Cancer Center in New York. She received a B.A. from New York University and an M.D. from Mount Sinai School of Medicine. She completed her residency in internal medicine at Mount Sinai Hospital and her fellowship in medical oncology at Memorial Sloan Kettering Cancer Center.